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射频设备治疗鼻中隔偏曲引起的鼻气道阻塞的两年结果。

Two-year outcomes of radiofrequency device treatment of the nasal valve for nasal airway obstruction.

机构信息

Madison ENT and Facial Plastic Surgery, New York, NY, USA.

ENT Associates of Texas, McKinney, TX, USA.

出版信息

Rhinology. 2024 Jun 1;62(3):310-319. doi: 10.4193/RhinRhin23.377.

Abstract

BACKGROUND

Temperature-controlled radiofrequency (TCRF) device treatment of nasal valve dysfunction (NVD) was superior to a sham procedure control in reducing the symptoms of nasal airway obstruction (NAO) in this randomised controlled trial (RCT).

METHODOLOGY

Two-year outcomes for 108 patients actively treated in a prospective, multicenter, patient-blinded RCT were used to determine treatment effect durability and changes in medication/nasal dilator usage. A responder was defined as ≥ 20 reduction in NOSE score or 1 reduction in severity class.

RESULTS

The mean (SD) age of patients was 48.5 (12.3) years; 66 (61.1%) women. Baseline NOSE score was 76.3. The 2-year responder rate was 90.4% and NOSE score treatment effect was -41.7; 54.7% improvement. Of 57 patients using medications/nasal dilators at baseline, 45 (78.9%) either stopped all use (33.3%) or stopped/decreased (45.6%) use in >=1 class at 2 years. Concurrent septal deviation, septal swell body, or turbinate enlargement did not significantly affect the odds of exhibiting a NOSE score of ≤ 25 at 2 years.

CONCLUSIONS

TCRF device treatment of NVD resulted in significant and sustained improvements in the symptoms of NAO at 2 years, accompanied by a substantial reduction in medication/nasal dilator use.

摘要

背景

在这项随机对照试验(RCT)中,与假手术对照相比,温度控制射频(TCRF)设备治疗鼻阀功能障碍(NVD)可更有效地减轻鼻腔气道阻塞(NAO)症状。

方法

使用 108 例积极接受前瞻性、多中心、患者盲法 RCT 治疗的患者的两年结局来确定治疗效果的持久性和药物/鼻腔扩张器使用的变化。应答者定义为 NOSE 评分降低≥20 或严重程度分级降低 1 级。

结果

患者的平均(SD)年龄为 48.5(12.3)岁;66 例(61.1%)为女性。基线 NOSE 评分为 76.3。两年的应答率为 90.4%,NOSE 评分治疗效果为-41.7;改善 54.7%。在基线时使用药物/鼻腔扩张器的 57 例患者中,有 45 例(78.9%)在两年时停止了所有使用(33.3%)或停止/减少(45.6%)至少一种类别的使用。同期鼻中隔偏曲、鼻中隔肿胀体或鼻甲增大并不显著影响两年时 NOSE 评分≤25 的可能性。

结论

TCRF 设备治疗 NVD 可显著且持续地改善 NAO 症状,同时药物/鼻腔扩张器的使用也大幅减少。

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